The study evaluated several predictive models for major bleeding events in patients with atrial fibrillation and cerebral ischemia.

The ability of various risk prediction models to estimate the risk for major bleeding in patients with atrial fibrillation (AFib) and cerebral ischemia is modest, but these models may still be useful for optimizing treatment in Afib, according to findings from a study published in Stroke.

Researchers evaluated patients who were included in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial, all of whom had a clinical history of stroke or transient ischemic attack. Subjects in the RE-LY trial had AFib and were randomly assigned to receive either 110/150 mg dabigatran or warfarin twice daily.

In addition, the investigators examined the prognostic ability of various prediction models for the risk of major bleeding, including HEMORR2HAGES, Shireman, HAS-BLED, ATRIA, and ORBIT risk scores.

A total of 266 patients experienced major bleeding during the 6922 person-years of follow-up (3.8; 95% CI, 3.4-4.3 per 100 person-years). Performance of ATRIA as assessed by a calibration plot was poor, whereas the performance of the other models demonstrated moderate predictive ability. The prognostic capability of all models included in this analysis was greater in patients randomly assigned to receive dabigatran compared with warfarin. In addition, the investigators found that the benefit associated with warfarin in reducing recurrent ischemic strokes was greater than the risk for a major bleeding event.

The RE-LY trial excluded participants in the highest risk group for major bleeding, which presents a potential limitation of the study's findings. Thus, the modest performance of these risk prediction models may not be generalizable to all patients with Afib and cerebral ischemia.

Regardless of the study's limitations, the investigators suggest that the assessment “of bleeding risk may still be useful to identify modifiable risk factors for bleeding as well as to identify high-risk patients who might qualify for treatment with gastroprotective agents.”